Reasons for increasing importance of Pharmacovigilance (Phase IV) Trials

Top Quote Webinar : FDA-mandated post-market Phase IV clinical studies, with exacting endpoints and obligatory. Understand FDA mandatory objectives and timelines. End Quote
  • (1888PressRelease) April 16, 2015 - Overview: FDA-mandated post-market studies are here. Phase IV clinical studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines.

    Why Should You Attend:
    With the increasing complexity of therapeutic agents - now involving more "biologics" - and an increase of use of new agents beyond the original intention and testing, it is essential to know as early as possible any untoward and unexpected Adverse Events and other serious toxicities. The well-known examples of Drugs pulled from the market after approval attest to the need for Phase IV (Post marketing approval) surveillance.

    There is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. There are, however Guidance documents for "Risk Minimization Action Plans" and "Good Pharmacovigilance Practices and "Pharmacovigilance Studies" and there is also the ICH E2E Guidance of Pharmacovigilance Planning.

    There are a number of points that are only seen in Phase IV (PV) studies and why these are important in the Drug Development process will be covered. These studies (and there are several types of Phase IV/Post Marketing studies) answer important safety questions and because of this and the duration of these studies, they are almost always associated with Data Monitoring Committees(DMC)

    Areas Covered in the Session:
    What are the types of Phase IV studies
    The Nature of the I/E criteria in Phase IV studies
    How does the Safety Monitoring Plan differ in Phase IV
    What constitutes a "rare" adverse event?
    Why large studies are needed to uncover rare Serious Adverse Events
    What is the role and value of a DMC in large studies
    What endpoints is the FDA looking for once they have approved a drug/device
    What agents have been pulled after approval and why?

    Learning Objectives:
    Identify the main differences between Pre-market and Post-market studies
    Contrast the elements of type II or 'rare' Adverse Events with type I Adverse Events
    Describe three AE mechanisms how an agent would be removed from the market after it had been approved

    Who Will Benefit:
    Pharmaceutical, Biological and Device Companies
    Principal Investigators and Sub Investigators
    Clinical Research Scientists (PKs, Biostatisticians) Research Managers
    Safety Nurses
    Clinical Research Associates and Coordinators
    Recruiting staff
    QA / QC auditors and staff
    Study Monitors
    Clinical Research Data managers

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